30 Results
NIH Study Finds Tecovirimat Was Safe but Did Not Improve Mpox Resolution or Pain
December 10, 2024
Tecovirimat was safe but did not reduce the time to lesion resolution or reduce pain among adults with mild to moderate clade II mpox and a low risk of severe disease in an international study.
The Antiviral Tecovirimat is Safe but Did Not Improve Clade I Mpox Resolution in Democratic Republic of the Congo
August 15, 2024
The antiviral drug tecovirimat did not reduce the duration of mpox lesions among children and adults with clade I mpox in the Democratic Republic of the Congo (DRC), based on an initial analysis of data from a randomized, placebo-controlled trial. However, the study’s 1.7% overall mortality among enrollees, regardless of whether they received the drug or not, was much lower than the mpox mortality of 3.6% or higher reported among all cases in the DRC. This shows that better outcomes among people with mpox can be achieved when they are hospitalized and provided high-quality supportive care.
Candidate Malaria Vaccine Provides Lasting Protection in NIH-Sponsored Trials
August 14, 2024
Two National Institutes of Health (NIH)-supported trials of an experimental malaria vaccine in healthy Malian adults found that all three tested regimens were safe. One of the trials enrolled 300 healthy women ages 18 to 38 years who anticipated becoming pregnant soon after immunization. That trial began with drug treatment to remove malaria parasites, followed by three injections spaced over a month of either saline placebo or the investigational vaccine at one of two dosages.
Exploratory Analysis Associates HIV Drug Abacavir with Elevated Cardiovascular Disease Risk in Large Global Trial
July 23, 2024
Current or previous use of the antiretroviral drug (ARV) abacavir was associated with an elevated risk of major adverse cardiovascular events (MACE) in people with HIV, according to an exploratory analysis from a large international clinical trial primarily funded by the National Institutes of Health (NIH). There was no elevated MACE risk for the other antiretroviral drugs included in the analysis. The findings will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
NIH Statement on Preliminary Efficacy Results of Twice-Yearly Lenacapavir for HIV Prevention in Cisgender Women
June 26, 2024
The injectable antiretroviral drug lenacapavir was safe and 100% effective as long-acting HIV pre-exposure prophylaxis (PrEP) among cisgender women in a Phase 3 clinical trial, according to top-line findings released by Gilead Sciences, Inc., the study sponsor. Lenacapavir is administered every six months, making it the most durable HIV prevention method to have shown efficacy in this population.
Experimental NIH Malaria Monoclonal Antibody Protective in Malian Children
April 26, 2024
One injected dose of an experimental malaria monoclonal antibody was 77% effective against malaria disease in children in Mali during the country’s six-month malaria season, according to the results of a mid-stage clinical trial. The trial assessed an investigational monoclonal antibody developed by scientists at the National Institutes of Health (NIH), and results appear in The New England Journal of Medicine.
World TB Day 2024 – Yes! We Can End TB!
March 22, 2024
In observance of World Tuberculosis Day (Sunday, March 24), NIAID joins our partners in reaffirming our commitment to ending the tuberculosis (TB) pandemic while honoring the lives lost to TB disease.
Biomedical STI Prevention Evidence Is Inadequate for Cisgender Women
December 20, 2023
Pivotal studies of some biomedical HIV and sexually transmitted infection (STI) prevention interventions have excluded cisgender women or demonstrated low efficacy among them, limiting their prevention options relative to other populations who experience high HIV and STI incidence. Findings show doxycycline postexposure prophylaxis (better known as DoxyPEP) did not prevent STI acquisition in cisgender women, despite showing promising results in gay, bisexual, and other men who have sex with men and transgender women in a previous study.
Clinical Trial to Test Immune Modulation Strategy for Hospitalized COVID-19 Patients Begins
September 22, 2023
A clinical trial has launched to test whether early intensive immune modulation for hospitalized COVID-19 patients with relatively mild illness is beneficial. The placebo-controlled study will enroll approximately 1,500 people at research sites around the world.
Investigational Three-Month TB Regimen Is Safe but Ineffective, NIH Study Finds
July 5, 2023
The first clinical trial of a three-month tuberculosis (TB) treatment regimen is closing enrollment because of a high rate of unfavorable outcomes with the investigational course of treatment. Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) 5362, also known as the CLO-FAST trial, sought to evaluate the safety and efficacy of a three-month clofazimine- and high-dose rifapentine-containing regimen. An interim data analysis showed that participants taking the investigational regimen experienced ongoing or recurring TB at rates above thresholds set in the study protocol.
NIAID Marks World Malaria Day
April 25, 2023
World Malaria Day is an opportunity to reflect on continuing challenges posed by malaria and reaffirm a commitment to overcoming them. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, joins with the global health community in recognizing this year’s theme of “Time to Deliver on Zero Malaria: Invest, Innovate, Implement.”
World TB Day 2023 – ‘Yes! We Can End TB!’
March 24, 2023
Each year, on March 24, the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, joins people and organizations from around the globe in marking World Tuberculosis Day. On this day, more than 140 years ago, Dr. Robert Koch announced his discovery that most human tuberculosis (TB) is caused by the bacterium Mycobacterium tuberculosis (Mtb). Although our scientific insight into this disease has grown over the past century, TB is still one of the deadliest infectious diseases on the planet. Today, NIAID joins the world in a message of hope: “Yes!
Ebola Vaccine Regimens Safe, Immunogenic in Adults and Children
December 14, 2022
Two randomized, placebo-controlled trials evaluating three Ebola vaccine administration strategies in adults and children found that all the regimens were safe in both age groups, according to results published today in the New England Journal of Medicine. Antibodies were produced in response to the vaccine regimens beginning at 14 days after the first vaccination and continued to be detectable at varying levels—depending on the vaccine and regimen used—in both children and adults for one year.
Monoclonal Antibody Prevents Malaria Infection in African Adults
October 31, 2022
One dose of an antibody drug safely protected healthy, non-pregnant adults from malaria infection during an intense six-month malaria season in Mali, Africa, a National Institutes of Health clinical trial has found. The antibody was up to 88.2% effective at preventing infection over a 24-week period, demonstrating for the first time that a monoclonal antibody can prevent malaria infection in an endemic region.
Monkeypox Treatment Trial Begins in the Democratic Republic of the Congo
October 12, 2022
A clinical trial to evaluate the antiviral drug tecovirimat, also known as TPOXX, in adults and children with monkeypox has begun in the Democratic Republic of the Congo (DRC). The trial will evaluate the drug’s safety and its ability to mitigate monkeypox symptoms and prevent serious outcomes, including death. NIAID and the DRC’s National Institute for Biomedical Research (INRB) are co-leading the trial as part of the government-to-government PALM partnership. Collaborating institutions include the U.S. Centers for Disease Control and Prevention (CDC), the Institute of Tropical Medicine Antwerp, the aid organization Alliance for International Medical Action (ALIMA) and the World Health Organization (WHO).
Monoclonal Antibody Prevents Malaria in U.S. Adults, NIH Trial Shows
August 4, 2022
One injection of a candidate monoclonal antibody (mAb) known as L9LS was found to be safe and highly protective in U.S. adults exposed to the malaria parasite, according to results from a National Institutes of Health Phase 1 clinical trial published in The New England Journal of Medicine.
NIAID Marks World Malaria Day
April 25, 2022
Malaria is one of the world’s most widespread and ancient infectious diseases, and controlling it remains a critical public health priority. This complex parasitic disease, transmitted from person to person by the bite of infected mosquitoes, threatens the lives and livelihoods of millions of people in tropical areas around the globe. Each year, on April 25, World Malaria Day provides an opportunity to reflect on recent advances in controlling this disease and the challenges that remain.
NIH Supports Valley Fever Research with New Awards
February 2, 2022
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has announced three awards to establish a network of Coccidioidomycosis Collaborative Research Centers to conduct research on coccidioidomycosis, also known as Valley Fever. These multi-disciplinary research teams will collaborate to investigate potential diagnostics, therapeutics, and vaccines for this fungal disease.
Hyperimmune Intravenous Immunoglobulin Does Not Improve Outcomes for Adults Hospitalized with COVID-19
January 27, 2022
A clinical trial has found that the combination of remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, is not more effective than remdesivir alone for treating adults hospitalized with the disease. The trial also found that the safety of this experimental treatment may vary depending on whether a person naturally generates SARS-CoV-2-neutralizing antibodies before receiving it. The results of the multinational Phase 3 trial were published today in the journal The Lancet.
Statement—NIH Celebrates FDA Approval of Long-Acting Injectable Drug for HIV Prevention
December 21, 2021
Yesterday the U.S. Food and Drug Administration announced its first approval of a long-acting HIV prevention medication. Developed by ViiV Healthcare, the medicine is long-acting cabotegravir injected once every two months. FDA has approved the medicine for use by adults and adolescents weighing at least 35 kilograms who are at risk of sexually acquiring HIV. This milestone marks a vital expansion of biomedical HIV prevention options available to people in the United States.
NIH Statement on World AIDS Day
December 1, 2021
Since 1988, World AIDS Day has been an annual call to end the HIV/AIDS pandemic as we remember the many who lost their lives to the disease. Considerable progress has been made since the first World AIDS Day; however, far too many people continue to acquire HIV and die from its related illnesses. In 2020, an estimated 680,000 people globally died from HIV-related causes, and roughly 1.5 million people became newly infected with HIV, according to the World Health Organization (WHO).
Too Many People with HIV Fail to Achieve Durable Viral Suppression
November 29, 2021
Among people with HIV worldwide who are receiving antiretroviral therapy (ART), adults are getting closer to the global target of 95% achieving viral suppression, but progress among children and adolescents is lagging and long-term viral suppression among all groups remains a challenge. These findings of a study funded by the National Institutes of Health suggest that substantial efforts are needed to help people with HIV durably suppress the virus. The findings were published today in the journal The Lancet HIV.
NIH Researchers Identify How Two People Controlled HIV After Stopping Treatment
October 28, 2021
Research led by scientists at the National Institutes of Health has identified two distinct ways that people with HIV can control the virus for an extended period after stopping antiretroviral therapy (ART) under medical supervision. This information could inform efforts to develop new tools to help people with HIV put the virus into remission without taking lifelong medication, which can have long-term side-effects.
Subcutaneous Interferon Does Not Improve Outcomes for Hospitalized Adults with COVID-19
October 18, 2021
A clinical trial has found that treatment with the immunomodulator interferon beta-1a plus the antiviral remdesivir was not superior to treatment with remdesivir alone in hospitalized adults with COVID-19 pneumonia. In addition, in a subgroup of patients who required high-flow oxygen, investigators found that interferon beta-1a was associated with more adverse events and worse outcomes. These findings were published today in the journal The Lancet Respiratory Medicine.
Monoclonal Antibody Prevents Malaria in Small NIH Trial
August 11, 2021
One dose of a new monoclonal antibody discovered and developed at the National Institutes of Health safely prevented malaria for up to nine months in people who were exposed to the malaria parasite. The small, carefully monitored clinical trial is the first to demonstrate that a monoclonal antibody can prevent malaria in people. The trial was sponsored and conducted by scientists from the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and was funded by NIAID.